Urethral urine retention device

Abstract

An apparatus for sealing at least a portion of the urinary tract to prevent the unwanted discharge of urine includes a body member with a tubular member, encircled along its length by an overcoat layer, that encases a fluid, forming a cavity. The body member, with its tubular member and overcoat layer are elastically deformable from an initial “rest” or “relaxed” state, when outside of the body, where at least a portion of the overcoat layer is of a diameter equal to or greater than that of an undilated urethra. A stylet may be placed into the tubular member to serve as a guide, for elongation of the body member and to provide rigidly to the body member upon insertion into the urinary tract. There is also disclosed a method for making the apparatus of the present invention.

What is claimed is:  
     
       1. A method for producing a shaped article, for use within a patient's urinary tract for blocking the flow of urine therein, said method comprising: 
       (a) providing an inner member, at least a portion of said inner member having a diameter less than that of an undilated mammalian urethra;  
       (b) forming a shaped structure on said inner member by applying a residual coating of a bond-preventing agent onto at least a portion of said inner member, and shaping said residual coating into at least a plurality of continuous sections, each of said plurality of continuous sections including at least a portion of a diameter at least as great as that of an undilated mammalian urethra, said inner member and said residual coating defining an intermediate structure, wherein said intermediate structure is defined by a proximal and a distal region wherein said proximal region has a diameter that is smaller than the diameter of said distal region; and  
       (c) coating the intermediate structure with a liquid to form a shaped overcoat layer having a shape retaining memory, wherein the shape of the overcoat layer results from the shape of said residual coating of said bond-preventing agent; the shaped overcoat layer and the inner member defining a deformable body member being adapted for at least partial insertion into at least the urethra, the body member including a deformable fluid filled cavity having the residual coating therein; the cavity extending along the inner member and having a proximal end and a distal end, at least a portion of the shaped article having an at rest diameter greater than that of the undilated mammalian urethra, the shaped article including a distally positioned bulbous portion and a proximally positioned sleeve portion, a diameter of the bulbous portion at its widest point being greater than a diameter of the sleeve portion.  
     
     
       2. The method of  claim 1 , wherein at least a portion of said overcoat layer is of a diameter greater than that of an undilated mammalian urethra. 
     
     
       3. The method of  claim 1 , wherein said inner member includes an elastomeric tube, said tube including an open proximal end and a closed distal end. 
     
     
       4. The method of  claim 1 , wherein said residual coating is applied by a plurality of dipping steps and said shaping of said residual coating includes said plurality of dipping steps. 
     
     
       5. The method of  claim 1 , wherein said shaping of said residual coating includes stripping portions of said residual coating. 
     
     
       6. The method of  claim 3 , wherein said at least a plurality of continuous sections extend along said elastomeric tube at said portion having a diameter less than that of an undilated mammalian urethra. 
     
     
       7. The method of  claim 3 , additionally comprising, placing an opening in the closed distal end of said elastomeric tube. 
     
     
       8. The method of  claim 1 , additionally comprising replacing the residual coating of said intermediate structure with a fluid. 
     
     
       9. The method of  claim 8 , wherein said fluid includes mineral oil. 
     
     
       10. A method for producing a shaped article for use within a patient's urinary tract for blocking the flow of urine therein, said method comprising: 
       (a) providing an inner member, at least a portion of said inner member having a diameter less than that of an undilated mammalian urethra;  
       (b) forming a shaped structure on said inner member by applying a residual coating of a bond-preventing agent onto at least a portion of said inner member, wherein the application of said residual coating can be modified by either continuously or intermittently varying the rate of withdrawal of the inner member from a single diptank, and shaping said residual coating into at least a plurality of continuous sections, each of said plurality of continuous sections including at least a portion of a diameter at least as great as that of an undilated mammalian urethra, said inner member and said residual coating defining an intermediate structure; and  
       (c) coating the intermediate structure with a liquid to form a shaped overcoat layer having a shape retaining memory, wherein the shape of the overcoat layer results from the shape of said residual coating of said bond-preventing agent; the shaped overcoat layer and the inner member defining a deformable body member being adapted for at least partial insertion into at least the urethra, the body member including a deformable fluid filled cavity having the residual coating therein; the cavity extending along the inner member and having a proximal end and a distal end, at least a portion of the shaped article having an at rest diameter greater than that of the undilated mammalian urethra, the shaped article including a distally positioned bulbous portion and a proximally positioned sleeve portion, a diameter of the bulbous portion at its widest point being greater than a diameter of the sleeve portion.  
     
     
       11. A method for producing a shaped article for use within a patient's urnary tract for blocking the flow of urine therein, said method comprising: 
       (a) providing an inner member, at least a portion of said inner member having a diameter less than that of an undilated mammalian urethra;  
       (b) forming a shaped structure on said inner member by applying a residual coating of a bond-preventing agent onto at least a portion of said inner member, wherein the application of said residual coating can be modified by either continuously or intermittently varying the rate of withdrawal of the inner member from a single diptank, and shaping said residual coating into at least a plurality of continuous sections, each of said plurality of continuous sections including at least a portion of a diameter at least as great as that of an undilated mammalian urethra, said inner member and said residual coating defining an intermediate structure, wherein said intermediate structure is defined by a proximal and a distal region wherein said proximal region has a diameter that is smaller than the diameter of said distal region; and  
       (c) coating the intermediate structure with a liquid to form a shaped overcoat layer having a shape retaining memory, wherein the shape of the overcoat layer results from the shape of said residual coating of said bond-preventing agent; the shaped overcoat layer and the inner member defining a deformable body member being adapted for at least partial insertion into at least the urethra, the body member including a deformable fluid filled cavity having the residual coating therein; the cavity extending along the inner member and having a proximal end and a distal end, at least a portion of the shaped article having an at rest diameter greater than that of the undilated mammalian urethra, the shaped article including a distally positioned bulbous portion and a proximally positioned sleeve portion, a diameter of the bulbous portion at its widest point being greater than a diameter of the sleeve portion.